Heart Health After Cancer Treatment (HEART-ACT)

NCT06055803 | Active Not Recruiting DMC

• 2 other identifiers: 228014NCI-2023-07108
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study testing multi-disciplinary health behavior intervention in breast cancer survivors who have been treated at Zuckerberg San Francisco General (ZSFG).

Conditions

Breast Cancer

Keywords

Health Behavioral Program; Cardiac Health

Outcome Measures

Primary Outcomes (3)

• Proportion of participants with analyzable data for change in 6 Minute Walk Distance (6MWD)

  6MWD measures the distance walked over 6 minutes. The farther a person can walk indicates better exercise tolerance and mobility. The changes in distance will be compared at baseline and 12 months. We will measure the proportion of participants with analyzable 6MWD data.

  Baseline to 12 months

• Proportion of participants with analyzable data for change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Mental Scale

  The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The mental health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better mental health. We will calculate the change in the score between baseline and 12 months. The proportion of participants who can have a score measured will be calculated.

  Baseline to 12 months

• Proportion of participants with analyzable data for change in PROMIS Global Health - Physical Health Scale

  The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health. We will calculate the change in the score between baseline and 12 months.

  Baseline to 12 months

Secondary Outcomes (12)

• Net Promoter Score

  3 Months

• Net Promoter Score

  6 Months

• Net Promoter Score

  12 Months

• Change in 6MWD

  Baseline and 12 Months

• Change in 6MWD

  Baseline and 6 Months

Study Arms (1)

Health Behavior Program

EXPERIMENTAL

Each participant will have an individualized assessment with plan and goals set at the program intake visit. Program components will include: Physical Activity, Nutrition, Emotional Well-being, Cardiovascular Risk, Survivorship, and other items individualized to the participant as needed (e.g., tobacco cessation). The 12-week program will alternate between group and individual sessions each week. Individualized plans will be reviewed every two weeks at the participant individual sessions.

Behavioral: Intake Session; Behavioral: Individual Sessions; Behavioral: Group Sessions; Behavioral: Graduation; Behavioral: Exercise

Interventions

Intake Session BEHAVIORAL

Each of the program components will have an individualized assessment with plan and goals set at the program intake visit.

Health Behavior Program

Individual Sessions BEHAVIORAL

Individual sessions will occur in person or virtual every other week during the 12-week intervention with a health promotion specialist (nurse or exercise physiologist). These sessions will include review of progress towards goals, update exercise prescription, make plan for the next two weeks.

Health Behavior Program

Group Sessions BEHAVIORAL

Group sessions for wellness and education will be delivered by medical multi-disciplinary staff in person or virtual every other week during the 12-week intervention.

Health Behavior Program

Graduation BEHAVIORAL

At the conclusion of the 12-week intervention, there will be a graduation session to honor the participant's achievement and establish a plan for maintenance after the intervention

Health Behavior Program

Exercise BEHAVIORAL

Participants will exercise as part of individual and group sessions. Participants will also be asked to exercise on their own, with a goal of working up to meeting US Physical Activity guidelines (150 minutes per week of moderate to vigorous exercise + 2 episodes of strength training).

Health Behavior Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Diagnosis of breast cancer
• Treated with curative intent
• Able to communicate in English, Spanish, or Cantonese
• Able to consent for self
• Receive care at Zuckerberg San Francisco General Hospital

You may not qualify if:

• Chemotherapy, radiation, or surgery planned in next 3 months
• Life expectancy \< 1 year

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alexis Beatty, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: November 7, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)